Effectiveness of an Enhanced Tobacco Intervention Protocol Compared to Standard Treatment in Helping Head and Neck and Lung Cancer Patients Starting Treatment to Reduce Cigarette Use

NCT04694846 | Completed

• 2 other identifiers: 19D.866JT 14301
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

This trial studies how well an enhanced tobacco intervention protocol (ETIP) works compared to standard treatment in helping head and neck and lung cancer patients starting treatment to reduce cigarette use. ETIP is an evidence-based tobacco cessation program including specialized one-to-one and telehealth counseling, drug therapy, nicotine replacement therapy, and frequent patient follow up. ETIP may help reduce smoking and improve cessation in patients with head and neck squamous cell cancer or non-small cell lung cancer.

Conditions

Lung Non-Small Cell Carcinoma; Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Reduction in daily number of cigarettes smoked by at least 50% compared to baseline at months 1 and 6

  This will be biochemically verified by any reductions in minor tobacco alkaloid (anabasine/anatabine) concentrations in the urine compared to baseline

  Up to 6 months

Secondary Outcomes (2)

• Cigarette abstinence at 1 and 6 months, as reported by patients

  Up to 6 months

• Proportion of patients having urine anabasine/anatabine levels of less than 2ng/ml

  Up to 6 months

Other Outcomes (5)

• Interest expressed in wellness practices

  Up to 6 months

• Types of wellness practices patients prefer

  Up to 6 months

• Likelihood of patient participation

  Up to 6 months

Study Arms (2)

Arm I (ETIP)

EXPERIMENTAL

Patients receive nicotine replacement therapy via trans-dermal patch, gum, nasal spray, inhaler or lozenges for 12 weeks in the absence of unacceptable toxicity. Patients also receive bupropion PO QD BID or varenicline PO QD and BID for 24 weeks in the absence of unacceptable toxicity. Patients undergo 3 cessation counseling sessions in person, via telehealth or phone within 7 days of enrollment into study, 1 week after established quit date and 3 weeks after establishing quit date.

Drug: Nicotine Replacement; Drug: Bupropion Hydrochloride Controlled-release; Drug: Varenicline; Other: Tobacco Cessation Counseling; Other: Questionnaire Administration; Other: Quality of Life Assessment

Arm II SOC

ACTIVE COMPARATOR

Participants randomly assigned to the standard treatment (ST) group will receive an in-office smoking cessation recommendation by the physician and referral to a quit line.

Other: Questionnaire Administration; Other: Quality of Life Assessment; Other: Best Practice

Interventions

Nicotine Replacement DRUG

Given NRT via trans-dermal patch, gum, nasal spray, inhaler or lozenges

Also known as: nicotine replacement therapy, Nicotine Replacement Therapy, NRT

Arm I (ETIP)

Bupropion Hydrochloride Controlled-release DRUG

Given PO

Also known as: Bupropion HCl Controlled-release, Bupropion HCl Extended Release, Bupropion Hydrochloride Extended-Release, Forfivo XL, Wellbutrin SR, Wellbutrin XL, Zyban, Zyban

Arm I (ETIP)

Varenicline DRUG

Given PO

Also known as: 249296-44-4, 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino(2,3-h)(3)benzazepine (2R,3R)-2,3-dihydroxybutqanedioate, Champix, Chantix, CP-526555, VARENICLINE

Arm I (ETIP)

Tobacco Cessation Counseling OTHER

Receive counseling

Arm I (ETIP)

Questionnaire Administration OTHER

Ancillary studies

Arm I (ETIP); Arm II SOC

Quality of Life Assessment OTHER

Ancillary studies

Arm I (ETIP); Arm II SOC

Best Practice OTHER

Receive standard treatment

Also known as: best practice, standard of care, standard of care, standard therapy

Arm II SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide signed written informed consent document
• New patients opting to receive cancer care at Thomas Jefferson University Hospital (TJUH) or Methodist with suspected or newly diagnosed head and neck squamous cell carcinoma (HNSCC) or non-small cell carcinoma of the lung
• Must have a life expectancy of at least 6 months as judged by the treating physician
• Willing to discuss changing their smoking behavior
• Patients have smoked \> 100 cigarettes in their lifetime and have smoked within the last 30 days
• Subjects must read and speak fluent English

You may not qualify if:

• Patients with psychiatric disorders with indications of current uncontrolled illness, or patients currently being treated on psychiatric medications
• Patients with expected survival of less than 6 months or other medical illness that would prevent participation as determined by the treating clinician
• Patients not fluent in English will be excluded, as the counselling component of the intervention is only available in English
• Pregnant or breastfeeding women
• Severe swallowing disorders or other illness that would impede a patient's ability to swallow medications in pill form
• Patients with impaired judgement or those unable to provide informed consent
• Contraindications to nicotine replacement therapy:
• All free flap patients: Nicotine replacement therapy (NRT) and tobacco products must not be used by these patients for at least 2 weeks before and 2 weeks after free flap surgery. For planned procedures involving face and breast, tobacco and NRT use should be avoided 4 weeks before and 4 weeks after surgery
• Patients in the immediate (within 2 weeks) post myocardial infarction period or who have serious arrhythmias or unstable angina pectoris
• Patient who are hemodynamically or electrically unstable or have had orthopedic surgery or a serious fracture(s) within the past 6 weeks
• Patients with known allergy or hypersensitivity to NRT, or severe skin reactions like Steven's Johnson syndrome
• Contraindications to bupropion or varenicline:
• Pre-existing seizure disorder or conditions that increase the risk of seizures (e.g., severe head trauma, arteriovenous malformation, central nervous system (CNS) tumor (e.g., brain tumor or intracranial mass), CNS infection, severe stroke, anorexia nervosa, bulimia nervosa
• Patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs
• Concomitant use of anti-depressants

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (2)

Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy

Philadelphia, Pennsylvania, 19107, United States

Location

Jefferson Health, Methodist Hospital

Philadelphia, Pennsylvania, 19148, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck

Interventions

Nicotine Replacement Therapy; Bupropion; Varenicline; Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Propiophenones; Ketones; Organic Chemicals; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: January 5, 2021
• Study Start: August 19, 2020
• Primary Completion: August 16, 2024
• Study Completion: August 16, 2024
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)